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Biotech News

FDA Approval of Antibiotic for Bacterial Pneumonia Expected in Late Summer
May 17, 2019 (Investorideas.com Newswire) An update on this biopharma's two lead drug candidate programs was provided in an H.C. Wainwright report.

Why Did ImmunoGen Plummet 32%?
May 17, 2019 (Investorideas.com Newswire) This biotechnology company, which focuses on the treatment of cancer, received some feedback from the FDA that upset investors on Wednesday.

Pharma stocks: Biocure (CSE: CURE) (OTCQB: BICTF) Enters into Exclusive Joint R&D Agreement with Pharos Vaccine Inc. for Overseas Market of CAR T-Cell Products
Vancouver, British Columbia - May 16, 2019 (Newsfile Corp.) (Investorideas.com Newswire) Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (formerly Gravis Energy Corp.) (the "Company" or "Biocure") is pleased to announce that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis.

Trial Milestone Reached; U.K.-Based Biopharma Gets $15 Million
May 9, 2019 (Investorideas.com Newswire) The first patient has been treated in the second cohort of a Phase 2 study of a gene therapy targeting Parkinson's disease, explained an H.C. Wainwright & Co. report.

Shares of Plant-Based Meat Company Spike 53% (and It's Not Beyond Meat)
May 7, 2019 (Investorideas.com Newswire) This small-cap nutrascience stock hit a new 52-week high on May 6th, extending a run that has the stock up 147% over a five-day period.

US and Canada Clinical Laboratories to Strike the 100 Billion Market Cap
Santa Clara, Calif. - May 6, 2019 (Investorideas.com Newswire) The growing trend of decentralization has expanded the scope of testing beyond the traditional laboratory environment.

'Pivotal Topline Up Next' for Biotech's Phase 3 Cardiac Clinical Trial
May 2, 2019 (Investorideas.com Newswire) A study update and the next steps to advance the therapeutic were covered in a ROTH Capital Partners report.

Immuno-Oncology Firm to Collaborate on Third Clinical Trial with Genentech
May 2, 2019 (Investorideas.com Newswire) Descriptions of the new study and upcoming data readouts for this California-based firm were provided in an H.C. Wainwright & Co. report.

Fitness May Affect Risk of Lung, Colorectal Cancer and Likelihood of Survival after Diagnosis
May 1, 2019 (Investorideas.com Newswire) In a recent study, adults who were the most fit had the lowest risk of developing lung and colorectal cancer.

'Undervalued' Biopharma Features Robust Pipeline, Future Upside
April 26, 2019 (Investorideas.com Newswire) The case for investing in this company was made in an H.C. Wainwright & Co. report.

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Biotech Stock ETF's

First Trust NYSE Arca Biotech ETF ( NYSEArca: FBT ) The investment seeks investment results that correspond generally to the price and yield (before the fund's fees and expenses) of an equity index called the NYSE Arca Biotechnology Index(SM). The fund will normally invest at least 90% of its net assets plus the amount of any borrowings for investment purposes in common stocks that comprise the index. The index is an equal-dollar weighted index designed to measure the performance of a cross section of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. The fund is non-diversified.

iShares US Healthcare ( NYSEArca: IYH ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Health Care Index (the "underlying index"), which measures the performance of the healthcare sector of the U.S. equity market. The fund is non-diversified.

iShares US Healthcare Providers ( NYSEArca: IHF ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare providers sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Select Health Care Providers Index (the "underlying index"), which measures the performance of the healthcare providers sector of the U.S. equity market. The fund is non-diversified.

iShares US Medical Devices ( NYSEArca: IHI ) The investment seeks to track the investment results of an index composed of U.S. equities in the medical devices sector. The fund seeks to track the investment results of the Dow Jones U.S. Select Medical Equipment Index (the "underlying index"), which measures the performance of the medical equipment sector of the U.S. equity market. The underlying index includes medical equipment companies such as manufacturers and distributors of medical devices such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, X-ray machines, and other non-disposable medical devices. The fund is non-diversified.

iShares Nasdaq Biotechnology ( NasdaqGIDS IBB ) The investment seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. The underlying index contains securities of NASDAQ® listed companies that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by the NASDAQ OMX Group, Inc. The fund is non-diversified.

Market Vectors Biotech ETF ( NYSE MKT:BBH ) seeks to replicate as closely as possible, before fees and expenses, the price and yield performance of the Market Vectors® US Listed Biotech 25 Index. The fund normally invests at least 80% of its total assets in securities that comprise the fund's benchmark index. The Biotech Index is comprised of common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology sector. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. It is non-diversified.

PowerShares Dynamic Biotech & Genome ETF ( NYSEArca: PBE ) The investment seeks investment results that generally correspond (before fees and expenses) to the price and yield of the Dynamic Biotechnology & Genome IntellidexSM Index. The fund generally will invest at least 90% of its total assets in common stocks of biotechnology companies and genome companies that comprise the underlying intellidex. The underlying intellidex was composed of common stocks of 30 U.S. biotechnology and genome companies. These companies are engaged principally in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes, etc. It is non-diversified.

Biotech News from Newsfile

Vivera Pharmaceuticals' TVIA Kit Featured in AJ McLean's Hit Music Video 'Boy and a Man'
Newport Beach, California--(Newsfile Corp. - May 16, 2019) - Vivera Pharmaceuticals, Inc., a pharmaceutical company focused on non-addictive pain management, today announces the appearance of its TVIA Kit™ in the hit video for the best-selling single "Boy and a Man" by Backstreet Boys member AJ McLean. The video has been viewed over one million times since its debut last month, and the song will appear on the recording artist's upcoming debut solo country album, Long ...

Biocure Enters into Exclusive Joint R&D Agreement with Pharos Vaccine Inc. for Overseas Market of CAR T-Cell Products
Vancouver, British Columbia--(Newsfile Corp. - May 16, 2019) - Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (formerly Gravis Energy Corp.) (the "Company" or "Biocure") is pleased to announce that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis. The two Companies will work together in developing anti-CD19 CAR T-cell therapy products, conduct preclinical, ...

Antler Gold Agrees to Purchase Mineral Assets from Sona Nanotech
Halifax, Nova Scotia--(Newsfile Corp. - May 16, 2019) - Antler Gold Inc. (TSXV: ANTL) ("Antler") and Sona Nanotech Inc. (CSE: SONA) ("Sona") are pleased to announce that they have entered into an agreement pursuant to which Antler will acquire from Sona a 100% interest in certain mineral claims comprising the Crescent Lake/KM61 molybdenum-copper-silver project located in Armstrong, Ontario (the "Property").Under the agreement, Antler will acquire the Property (the "Property Acquisition") in consideration of the ...

Vivera Pharmaceuticals Launches the TVIA Kit(TM) Featuring a Series of Non-Addictive, CBD-Based Products

The TVIA Kit(TM) is a revolutionary pharmaceutical product comprised of multiple drug delivery systems to maximize the benefits of CBD

Newport Beach, California--(Newsfile Corp. - May 14, 2019) - Vivera Pharmaceuticals, Inc., a pharmaceutical company focused on non-addictive pain management, today announces the debut of the TVIA Kit™, a revolutionary medical product containing multiple drug delivery systems for patients who are seeking a non-addictive solution for pain. The three-part system includes only lab-tested, hemp-derived cannabidiol (CBD) products formulated to maximize the benefits of the compound. A number of statistically significant studies on CBD highlight its ...

Sona Nanotech Inc. Announces Collaboration with University of Birmingham
Halifax, Nova Scotia--(Newsfile Corp. - May 9, 2019) - Sona Nanotech Inc.'s (CSE: SONA) mission to advance medical diagnostics took a step forward today with the announcement of a collaboration with the University of Birmingham in the UK to develop next generation nanorods for tissue imaging.The goal of the project, which is being led by Zoe Pikramenou, Professor of Inorganic Chemistry and Photophysics at the University of Birmingham, is to investigate whether gold nanorods can ...

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Biotech News from GlobeNewswire

Arrayit Corporation Aces Fifth Consecutive Proficiency Testing Round with a Top Laboratory Medicine Proficiency Testing Leader

Sunnyvale, May 20, 2019 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces that its clinical laboratory has aced five consecutive rounds of diagnostic immunology proficiency testing (PT) spanning three fiscal years 2017-2019. Proficiency testing requires the precise and accurate measurement of immunoglobulin E (IgE), the cellular biomarkers associated with allergy and asthma and reported in the company’s allergy test reports. A proficiency testing leader ships blinded specimens to Arrayit for testing, and Arrayit tests the specimens and reports the results for scoring to the independent agency. Because the acceptable test range is narrow, acing five consecutive rounds of PT is extremely demanding and requires a high degree of testing accuracy. Outstanding PT scores are valuable commercially because they expedite reimbursement by Medicare, Medicaid and the top commercial payors.  

Addex Increases Issued Share Capital and Creates Treasury Shares

Geneva, Switzerland, May 20, 2019 – Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, today announced that it has increased its capital from 28,564,031 to 32,848,635 through the issue of 4,284,604 new registered shares at a nominal value of CHF1 each to Addex Pharma S.A, its 100% wholly-owned subsidiary. The new shares, issued from the Company’s authorized capital, will be listed on the SIX Swiss Exchange from May 21, 2019. The transaction has been executed to provide the Group with additional treasury shares that can be used in the future to raise funds in an efficient manner.

“This transaction has been executed to provide us with future financing flexibility as we execute on our plans to start a pivotal registration study with dipraglurant in Parkinson’s disease levodopa-induced dyskinesia (PD-LID) by the end of 2019,” said Tim Dyer, CEO of Addex. “This is purely a preparatory step and we have no intention of using these new shares to raise capital in the current depressed market conditions.”

About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a biopharmaceutical company focused on the development of novel, orally available, small molecule allosteric modulators for neurological disorders. Allosteric modulators are an emerging class of small molecule drugs which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention - the Addex pipeline has been generated from this pioneering allosteric modulator drug discovery platform. Addex's lead drug candidate, dipraglurant (mGluR5 negative allosteric modulator or NAM) has successfully completed a Phase 2a POC in Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials for PD-LID. In parallel, dipraglurant's therapeutic use in dystonia is being investigated. Addex's second clinical program, ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc for epilepsy. In addition, Addex’s GABAB PAM program has been licensed to Indivior PLC for the treatment of addiction. Discovery programs include mGluR4PAM, mGluR7NAM, mGluR3PAM and TrkBPAM.

Press Contacts:

The US Department of Defense and Deinove will present impactful R&D results during the coming ASM 2019

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announces that Maj. Steven Zumbrun, Ph.D. from the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) will present, at the annual congress of the American Society of Microbiology, results of the DNV3681 in vitro evaluation against Bacillus anthracis and Francisella tularensis:

FDA and Infant Bacterial Therapeutics agree on the design of Phase III study

IBT has for an extended time consulted with the US Food and Drug Administration (FDA) on how the company's planned Phase III study should be designed. The FDA has now informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the study design and that there are currently no additions from the FDA's side. As a consequence of the FDA's comments, an evaluation of the effects of IBP-9414 on the digestive system of premature infants in the forthcoming Phase III study is now planned, as a serious medical problem for premature infants is that they cannot take up nourishment in an adequate way.

FDA och Infant Bacterial Therapeutics överens rörande Fas III studiens utformning

IBT har under en längre tid rådgjort med den amerikanska läkemedelsmyndigheten FDA (US Food and Drug Administration) angående hur företagets planerade fas III studie skall utformas. FDA har nu i skrift meddelat att IBT har tillfredsställande svarat på de kommentarer som FDA hade rörande studiedesignen och att det i dagsläget inte finns några tillägg från FDAs sida. Som ett resultat av FDAs kommentarer planeras nu även en utvärdering av IBP-9414 effekter på de för tidigt födda barnens matsmältningssystem i den förestående fas III studien, eftersom ett allvarligt medicinskt problem för de för tidigt födda barnen är att de inte kan ta upp näring på ett adekvat sätt.
             
Som tidigare meddelats har IBT även diskuterat den kliniska utvecklingsplanen PIP (paediatric investigation plan) med EMA (European Medicines Agency), vilket resulterade i att IBTs PIP godkändes under 2017.

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Biotech/ Pharma Stock Directory

Preview

4SC (XETRA: VSC.DE) is an innovative biotech company with a strong focus on clinical development. We discover and develop targeted small molecule drugs with an epigenetic mode of action for the treatment of cancer in indications with a high unmet medical need and major economic potential.

Aastrom Biosciences, Inc. (NasdaqCM: ASTM) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI(TM), a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.

ABBOTT LABORATORIES (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.76

Abeona Therapeutics Inc. (NasdaqCM:ABEO) develops and delivers gene therapy and plasma-based products for severe and life-threatening rare diseases. Abeona's lead programs are AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (MPS IIIB and IIIA). We are also developing ABO-201 (AAV CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, we are also developing rare plasma protein therapies including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD using our proprietary SDF™ (Salt Diafiltration) ethanol-free process.

Ablynx (Brussels: ABLX.BR) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease.

Acadia Pharmaceuticals Inc. (NasdaqGS: ACAD) is a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, for which we have reported positive Phase III trial results in Parkinson's disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. We are currently completing NDA-enabling clinical and manufacturing activities for pimavanserin and are planning to submit an NDA with the FDA near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer's disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from internal discoveries.

Access Pharmaceuticals, Inc. (OTC:ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.

AcelRx Pharmaceuticals, Inc. (NasdaqGM:ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.

Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders. Acorda markets three FDA-approved therapies including: AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda. Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure.

Acrux Limited (ASX:ACR.AX) is a dynamic Australian drug delivery business developing and commercialising a range of patient-preferred pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin. Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation, superior cosmetic acceptability, and simple, accurate and flexible dosing.

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